PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities

On 21 April 2022 the EMA issued PV guidance revision 2 on the Pharmacovigilance Risk Assessment Committee (PRAC) strategy.

The PRAC strategy has closed this gap with a concept for systematically measuring patient-relevant health outcomes of major regulatory interventions, shifting the focus of pharmacovigilance to those activities and regulatory tools that make a difference in daily healthcare.

The latest revision integrates the achievements over a five-year period since its launch, in the following four key activity areas:

  • effectiveness evaluation of risk-minimization measures;
  • effectiveness of pharmacovigilance processes;
  • enablers of effective pharmacovigilance and stakeholder engagement;
  • analytical methods for impact research.

The revised strategy also includes:

  • new information on how to prioritize and carry out impact research;
  • a review of industry-sponsored post-authorization safety studies evaluating the effectiveness of risk-minimization process improvements.
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